Management of the PDA Trial (PDA)

  • STATUS
    Recruiting
  • End date
    Mar 12, 2023
  • participants needed
    1116
  • sponsor
    NICHD Neonatal Research Network
Updated on 27 February 2022
prematurity
premature
active treatment
preterm birth

Summary

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.

Description

This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment.

Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team.

The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).

Details
Condition Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
Treatment Expectant Management, Active Treatment
Clinical Study IdentifierNCT03456336
SponsorNICHD Neonatal Research Network
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Postnatal age 48 hours -21 days
Infant 22 0/7 to 28 6/7 weeks gestation at birth
sPDA, as defined as
Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
Mild or Moderate Clinical Criteria with Large PDA on echocardiogram

Exclusion Criteria

Cardiopulmonary compromise
Known congenital heart disease (besides atrial septal defect or ventricular septal defect)
Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation)
Any condition which, in the opinion of the investigator, would preclude enrollment
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